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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; IMPLANTABLE PORT
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BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; IMPLANTABLE PORT Back to Search Results
Catalog Number 7707540J
Device Problems Break (1069); Fracture (1260); Leak/Splash (1354); Suction Problem (2170); Migration (4003)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation and a photo has been provided for review.The investigation of the reported event is currently underway.Medical device - expiration date: 04/2020.
 
Event Description
It was reported that approximately four years post port device implant via right subclavian vein for chemotherapy, during saline flush, the port device was allegedly unable to be aspirated due to subcutaneous leakage around the port body.Therefore, a computer tomography was performed which allegedly identified catheter break with distal fragment migration to the right heart.Reportedly, the distal catheter segment and port body were removed.The patient was reported as stable.
 
Event Description
It was reported that approximately four years post port device implant via right subclavian vein for chemotherapy, during saline flush, the port device was allegedly unable to be aspirated due to subcutaneous leakage around the port body.Therefore, a computer tomography was performed which allegedly identified catheter break with distal fragment migration to the right heart.Reportedly, the distal catheter segment and port body were removed.The patient was reported as stable.
 
Manufacturer Narrative
H10: manufacturing review: manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one port device with valved-catheter in two segments was received and evaluated.The proximal segment was returned attached to the port body.A complete circumferential break was noted approximately 1.0mm from the distal end of the cath-lock.Multiple punctures to port septum.Both edges of break were jagged and rounded.The port body with attached catheter segment and detached distal segment were separately patent to infusion and aspiration.Photos were also received.Seven photographs were received and evaluated.The first photo shows oneport device with valved-catheter in two segments with one segment consisting of the proximal part of port body with cath-lock and the other segment showing the proximal part of the catheter, the catheter break appears to be close to the proximal end of catheter.The second photo shows a close-up of a complete circumferential break of catheter.Tubing.The third photo shows another close-up of a complete circumferential break of catheter tubing.The fourth photo shows a distant shot of one port device with valved-catheter in two segments with the port body detached from rest of catheter.The fifth and sixth photo appear identical showing the port body and cath-lock detached from proximal end of catheter.The seventh photo shows the circumferential breaks of the matching ends of catheter tubing with one segment of catheter tubing attached to port body and the other segment of tubing of catheter.The investigation from sample and photo review confirms the break issue.A definitive root cause could not be determined.H10: g4 h11: h3, h6 (device, results, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY
Type of Device
IMPLANTABLE PORT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9516401
MDR Text Key172604665
Report Number3006260740-2019-04003
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098246
UDI-Public(01)00801741098246
Combination Product (y/n)N
PMA/PMN Number
K050310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7707540J
Device Lot NumberREZD0144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Initial Date Manufacturer Received 11/29/2019
Initial Date FDA Received12/24/2019
Supplement Dates Manufacturer Received06/16/2020
Supplement Dates FDA Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CHEMOTHERAPY; CHEMOTHERAPY; CHEMOTHERAPY
Patient Outcome(s) Other; Required Intervention;
Patient Age81 YR
Patient Weight54
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